Disorders, RefractiveCECOTNCT02522416
A Comparison of Two Devices for Measuring the Central Thickness of the Cornea Before and After Surgery (CECOT)
An observational study of Disorders, Refractive, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial summary
Corneal topography allows the measure of the radii of curvature and of the thickness of the cornea. It is essential for diagnosis in ophthalmology and allows to highlight corneal irregularities such as a keratoconus, or too thin corneas which are a contra-indication for laser refractive surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Disorders, Refractive
- What is being tested?
- Central corneal thickness measurement
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 30 Nov 2015to 15 Mar 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients for whom a LASIK refractive surgery at the Adolphe de Rothschild ophthalmologic foundation is planned
Who may be able to join
- Patients for whom a LASIK refractive surgery is planned
Who cannot join
- hyperopic patient
- another refractive surgery technique
- pregnant or lactating woman
- patient's opposition to participation in the study, according to the law on research into routine care
- patient under a measure of legal protection
- absence of affiliation to social security
Trial locations and contacts
1 site in 1 country.
About this study
Corneal topography allows the measure of the radii of curvature and of the thickness of the cornea. It is essential for diagnosis in ophthalmology and allows to highlight corneal irregularities such as a keratoconus, or too thin corneas which are a contra-indication for laser refractive surgery.
Several types of corneal topographers are commercially available. Some as the Orbscan(r), operate by analyzing the image of the patterns of a Placido disk associated with a light slit, allowing the collection of thousands of points of the anterior and posterior surface of the cornea. More recent systems such as the Pentacam(r) are based on automatic rotary cameras which capture images of the whole anterior segment of the eye. The aim of this study is to compare two topographs, the Pentacam(r) and the Orbscan(r) and, more specifically, the central corneal pachymetry measurements measured pre- and postoperatively.
- Conditions
- Disorders, Refractive
- Being tested
- Central corneal thickness measurement
- Medical subject headings
- Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Central corneal thickness measurementDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Concordance of the Orbscan and Pentacam topographs, evaluated by the intra-class correlation coefficient, for the measure of the difference of the central thickness of the cornea before and after surgery.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2015 (estimated)
- Study start30 Nov 2015
- Primary completion30 Jan 2017
- Study completion15 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disorders, RefractiveStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02522416
- Sponsor's protocol ID
- JFO_2015_30
- Acronym
- CECOT
- Status last verified
- Mar 2017
- First submitted
- 11 Aug 2015
- Last updated
- 20 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Two Devices for Measuring the Central Thickness of the Cornea Before and After Surgery (CECOT)
- ClinicalTrials.gov ID
- NCT02522416
- Acronym / sponsor ID
- CECOT / JFO_2015_30
- Conditions
- Disorders, Refractive
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 30 Nov 2015 (actual)
- Primary completion
- 30 Jan 2017 (actual)
- Study completion
- 15 Mar 2017 (actual)
- First posted
- 13 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Corneal topography allows the measure of the radii of curvature and of the thickness of the cornea. It is essential for diagnosis in ophthalmology and allows to highlight corneal irregularities such as a keratoconus, or too thin corneas which are a contra-indication for laser refractive surgery.
Several types of corneal topographers are commercially available. Some as the Orbscan(r), operate by analyzing the image of the patterns of a Placido disk associated with a light slit, allowing the collection of thousands of points of the anterior and posterior surface of the cornea. More recent systems such as the Pentacam(r) are based on automatic rotary cameras which capture images of the whole anterior segment of the eye. The aim of this study is to compare two topographs, the Pentacam(r) and the Orbscan(r) and, more specifically, the central corneal pachymetry measurements measured pre- and postoperatively.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients for whom a LASIK refractive surgery at the Adolphe de Rothschild ophthalmologic foundation is planned
Key inclusion criteria (1 listed)
- Patients for whom a LASIK refractive surgery is planned
Key exclusion criteria (6 listed)
- hyperopic patient
- another refractive surgery technique
- pregnant or lactating woman
- patient's opposition to participation in the study, according to the law on research into routine care
- patient under a measure of legal protection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Central corneal thickness measurement | Device | – |
Primary outcome
Concordance of the Orbscan and Pentacam topographs, evaluated by the intra-class correlation coefficient, for the measure of the difference of the central thickness of the cornea before and after surgery.
Time frame: one month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Disorders, Refractive, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concordance of the Orbscan and Pentacam topographs, evaluated by the intra-class correlation coefficient, for the measure of the difference of the central thickness of the cornea before and after surgery. (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2017.